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Intermittent tri-weekly docetaxel plus bicalutamide in patients with castration-resistant prostate cancer: a single-arm prospective study using a historical control for comparison.

Abstract
Whether continuous docetaxel (DTX) chemotherapy offers an advantage over intermittent therapy for castration-resistant prostate cancer (CRPC) is unknown. In this study, we evaluated the efficacy, toxicity and quality of life (QoL) of intermittent tri-weekly DTX with bicalutamide in CRPC. Forty-two patients (group A) with CRPC were enrolled. The patients received intravenous DTX (75 mg m(-2)) once tri-weekly with oral bicalutamide (50 mg) once daily. Patients had a DTX holiday when the prostate-specific antigen (PSA) level declined ≥50%. DTX was restarted in patients with a PSA increase ≥25%. Sixty patients (group B) who had matching characteristics and had continuously received DTX without bicalutamide for 10-12 cycles were also enrolled. There were no statistically significant differences in progression-free survival (8 months vs. 9 months, P=0.866) or overall survival (19 months vs. 21 months, P=0.753) between groups A and B; however, the proportions of patients in group A with all grades of neutropenia (33% vs. 58%, P=0.013) and nausea/vomiting (11% vs. 29%, P=0.024) were significantly less compared to group B. A significant improvement in the global health and fatigue scores was recorded for group A post-chemotherapy compared to pre-chemotherapy (P<0.05). The fatigue, nausea/vomiting and appetite loss scores in group B were increased post-chemotherapy compared to pre-chemotherapy (P<0.05). In conclusion, intermittent tri-weekly DTX plus bicalutamide is well tolerated and has the potential to achieve comparable disease control with an improvement in QoL for patients with CRPC.
AuthorsYun-Fei Li, Shao-Feng Zhang, Tao-Tao Zhang, Lei Li, Wei Gan, Hong-Tao Jia, Sheng Xie, Hui-Hua Ji, Da-Lin He
JournalAsian journal of andrology (Asian J Androl) Vol. 15 Issue 6 Pg. 773-9 (Nov 2013) ISSN: 1745-7262 [Electronic] China
PMID23955552 (Publication Type: Controlled Clinical Trial, Journal Article)
Chemical References
  • Anilides
  • Nitriles
  • Taxoids
  • Tosyl Compounds
  • Docetaxel
  • bicalutamide
  • Prostate-Specific Antigen
Topics
  • Aged
  • Aged, 80 and over
  • Anilides (administration & dosage)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Case-Control Studies
  • Docetaxel
  • Drug Administration Schedule
  • Humans
  • Male
  • Middle Aged
  • Nitriles (administration & dosage)
  • Orchiectomy
  • Prospective Studies
  • Prostate-Specific Antigen (blood)
  • Prostatic Neoplasms (drug therapy, surgery)
  • Survival Analysis
  • Taxoids (administration & dosage)
  • Tosyl Compounds (administration & dosage)

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